A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Public ClinicalTrials.gov record NCT02267356. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines. This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months. The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.
Study identification
- NCT ID
- NCT02267356
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 259 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 17, 2015 (Actual)
- Primary completion
- Oct 18, 2016 (Actual)
- Completion
- Jul 7, 2017 (Actual)
- Last update posted
- Nov 4, 2020
2015 – 2017
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Kirklin Clinic of UAB Hospital | Birmingham | Alabama | 35233 | — |
| Radiant Research | Tucson | Arizona | 85712 | — |
| Dermatology Specialists, Inc | Oceanside | California | 92056 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| Center For Clinical Research | San Francisco | California | 94115 | — |
| Radiant Research | Santa Rosa | California | 95405 | — |
| International Dermatology Research | Miami | Florida | 33144 | — |
| Radiant Research | Pinellas Park | Florida | 33781 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Gateway Health Center | Newburgh | Indiana | 47630 | — |
| Mid Atlantic Research Center for Health | Baltimore | Maryland | 21214 | — |
| Associated Skin Care Specialist Minnesota Clinical Study Center | Minneapolis | Minnesota | 55432 | — |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| Forest Hills Dermatology Group | Forest Hills | New York | 11395 | — |
| Skin Search of Rochester | Rochester | New York | 14623 | — |
| Radiant Research | Akron | Ohio | 44311 | — |
| Radiant Research | Cincinnati | Ohio | 45249 | — |
| Radiant Research | Columbus | Ohio | 43212 | — |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Paddington Testing Company | Philadelphia | Pennsylvania | 19103 | — |
| Martin Foot and Ankle | York | Pennsylvania | 17402 | — |
| Radiant Research | Greer | South Carolina | 29621 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| The Skin Wellness Center | Knoxville | Tennessee | 37922 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| DermResearch | Austin | Texas | 78759 | — |
| J&S Clinical Studies | College Station | Texas | 77845 | — |
| Ashton Podiatry Associates, PA | Dallas | Texas | 75243 | — |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | — |
| The Education And Research Foundation, Inc. | Lynchburg | Virginia | 24501 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02267356, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02267356 live on ClinicalTrials.gov.